Avicenum PHLEBO 140 FINE tights

Organization name

ARIES, a.s.

SRN

CZ-MF-000047385

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  When not to use: Stop using the product immediately if any of the following conditions apply: • There are signs of mechanical damage – replace with new compression medical stockings • You notice a deterioration in your health that may be associated with the use of the compression medical device – consult your doctor in such case Contraindications: • Acute weeping skin manifestations • Acute limb ischaemia • Critical limb ischaemia • Decompensated cardiac insufficiency • Phlegmasia cerulea dolens, phlegmasia alba dolens • Hypersensitivity to materials used • Limb numbness disorders (e.g. peripheral neuropathy in diabetes mellitus)

Primary placement in Czechia; available across 1 country total.

Placed on the market in Czechia; per-country availability dates not published.

Trade name

Avicenum PHLEBO 140 FINE tights

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08590072891665

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

859007220140634

Reference / catalog number

NA

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The medical device intended for the compression therapy of venous conditions and swelling of the legs of various origin.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• L normal
• closed toe
• 8040

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• M030405COMPRESSION STOCKINGS

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.